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Topiramate (Epilepsy)
Overall results
Study description
Excluded studies
Table
Graphic
auto
during pregnancy (anytime or not specified)
1st trimester
2nd trimester
3rd trimester
2nd and/or 3rd trimester
throughout pregnancy
early pregnancy
days before delivery
late pregnancy
preconception-only
periconceptional
preconceptional for kinetic reason
at least 1st trimester
3 months (or more) before pregnancy or during pregnancy
1st and 2nd trimester
3 months or more before pregnancy or1st trimester
Paternal exp. genotoxic window only (0–3 months preconception)
Paternal exposure: epigenetic window only (3–xxx months preconception)
Paternal exposure: genotoxic/epigenetic window (0–xxx months preconception)
Paternal exposure: other window
Whatever the period exposition
individual studies
Outcome
TE
95% CI
n cases
n exposed
k
Pub. bias
Congenital malformations
All congenital malformations (majors, minors, majors and minors, or unspecified)
Morrow (Topiramate) (Controls unexposed, sick), 2006 Ornoy (Topiramate), 2008 Mawer (Topiramate) (Controls unexposed, sick), 2010 Veiby (Topiramate) (Controls unexposed, sick), 2014 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 Battino, 2024 Vajda (Topiramate) (Controls unexposed, sick), 2025 Hao (Controls unexposed, sick), 2025 The NAAED (Topiramate) (Epilepsy), 2025
10
2.28
[
1.62
; 3.21]
347
784
low
Major congenital malformations
Morrow (Topiramate) (Controls unexposed, sick), 2006 Ornoy (Topiramate), 2008 Mawer (Topiramate) (Controls unexposed, sick), 2010 Veiby (Topiramate) (Controls unexposed, sick), 2014 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 Battino, 2024 Vajda (Topiramate) (Controls unexposed, sick), 2025 Hao (Controls unexposed, sick), 2025 The NAAED (Topiramate) (Epilepsy), 2025
10
2.28
[
1.62
; 3.21]
347
784
low
Congenital heart defects
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018 Thomas (Topiramate) (Controls unexposed, sick), 2021
4
2.75
[
0.99
; 7.59]
32
233
not evaluable
Limb defects
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Vajda (Topiramate) (Controls unexposed, sick), 2013 Thomas (Topiramate) (Controls unexposed, sick), 2021
3
3.56
[
0.59
; 21.68]
5
81
not evaluable
Neural Tube Defects
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018
3
5.56
[
0.78
; 39.78]
2
224
not evaluable
Digestive system anomalies
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Topiramate) (Controls unexposed, sick), 2021
2
6.26
[
0.69
; 56.84]
4
37
not evaluable
Urinary malformations
Tomson (Topiramate), 2018 Thomas (Topiramate) (Controls unexposed, sick), 2021
2
1.68
[
0.22
; 13.11]
14
161
not evaluable
Hypospadias
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Topiramate), 2018
2
3.30
[
0.73
; 14.97]
14
180
not evaluable
Microcephaly / Small head circumference for gestational age
Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population), 2024
1
1.30
[
0.70
; 2.40]
710
290
not evaluable
Nervous system anomalies
Thomas (Topiramate) (Controls unexposed, sick), 2021
1
39.94
[
0.75
; 2134.65]
-
9
not evaluable
Oro-facial clefts
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Topiramate), 2018
2
7.95
[
0.83
; 76.53]
5
180
not evaluable
Spina bifida
Veiby (Topiramate) (Controls unexposed, sick), 2014
1
12.67
[
0.64
; 249.11]
3
43
not evaluable
Cleft lip with or without cleft palate
Vajda (Topiramate) (Controls unexposed, sick), 2013
1
3.37
[
0.07
; 172.23]
-
44
not evaluable
Polydactyly
Tomson (Topiramate), 2018
1
16.59
[
0.33
; 839.05]
-
152
not evaluable
Growth parameters and prematurity
Small for gestational age (weight)
Hernández-Díaz (Topiramate), 2017 Cohen (Topiramate) (Controls unexposed NOS), 2019 Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population), 2024
3
1.95
[
1.40
; 2.71]
44,113
684
not evaluable
Preterm (< 37 weeks)
Arkilo (Topiramate), 2015 Cohen (Topiramate) (Controls unexposed NOS), 2019
2
0.75
[
0.49
; 1.16]
160,598
2
not evaluable
Low birth weight (< 2500g)
Christensen (Topiramate) (Epilepsy) (Controls unexposed, general population), 2024
1
1.66
[
1.05
; 2.62]
1,027
290
not evaluable
Maternal consequences
Abruptio placentae (retroplacental hematoma)
Cohen (Topiramate) (Controls unexposed NOS), 2019
1
0.82
[
0.21
; 3.18]
20,260
-
not evaluable
Preeclampsia
Cohen (Topiramate) (Controls unexposed NOS), 2019
1
1.23
[
0.63
; 2.41]
53,625
-
not evaluable
Maternal consequences (as a whole)
Razaz (Topiramate), 2024
1
1.21
[
0.64
; 2.30]
666
249
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Arkilo (Topiramate), 2015 Trivedi (Topiramate) (Controls unexposed, sick), 2018 Meador (Topiramate) (Controls unexposed, sick), 2020 Vajda (Topiramate) (Controls unexposed sick), 2024 Moore (Topiramate) (Epilepsy) (Controls unexposed, sick), 2025
5
4.15
[
0.51
; 33.43]
106
98
not evaluable
Late intrauterine deaths (> 22 weeks) / Stillbirths
Arkilo (Topiramate), 2015 AlSheikh (Topiramate) (Controls unexposed, sick), 2020
2
15.37
[
0.63
; 376.77]
-
3
not evaluable
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions
Babic (Topiramate), 2014 Arkilo (Topiramate), 2015
2
8.47
[
0.57
; 125.19]
3
4
not evaluable
Neuro-developmental disorders
ASD (Autism spectrum disorder): Diagnosis/Risk
Wood (Topiramate), 2015 Bjørk (Topiramate) (Controls unexposed, sick), 2018 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Hernandez-Diaz, 2024 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024
6
1.54
[
0.85
; 2.78]
952
1,034
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Wood (Topiramate), 2015 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 Hernandez-Diaz, 2024
5
1.52
[
0.77
; 3.00]
924
1,028
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Bromley (Topiramate), 2016 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024
4
1.51
[
0.89
; 2.59]
1,502
431
not evaluable
Language disorders/delay
Bromley (Topiramate), 2016 Husebye (Topiramate) (Controls unexposed, sick), 2020 Meador (Topiramate) (Controls unexposed, disease free), 2021
3
1.76
[
0.63
; 4.86]
43
36
not evaluable
Neuro-developmental disorders (as a whole)
Arkilo (Topiramate), 2015 Bjørk (Topiramate) (Controls unexposed, sick), 2022 Moore (Topiramate) (Epilepsy) (Controls unexposed, sick), 2025
3
1.79
[
1.05
; 3.06]
507
268
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024
3
1.82
[
1.03
; 3.23]
1,502
404
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Bromley (Topiramate), 2016 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024
3
3.32
[
1.70
; 6.47]
394
388
not evaluable
ASD (Autism spectrum disorder): Risk
Wood (Topiramate), 2015 Bjørk (Topiramate) (Controls unexposed, sick), 2018
2
2.65
[
0.36
; 19.38]
28
7
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023 Madley-Dowd_SE (Topiramate) (Controls unexposed, sick), 2024
2
3.57
[
1.42
; 9.01]
388
361
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Thomas b (Controls unexposed, sick), 2022
1
1.05
[
0.24
; 4.62]
-
6
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Bjørk (Topiramate) (Controls unexposed, sick), 2022 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024
2
3.48
[
1.46
; 8.27]
143
289
not evaluable
Psychomotor developmental disorders/delay
Thomas b (Controls unexposed, sick), 2022
1
0.51
[
0.11
; 2.32]
-
6
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Bjørk (Topiramate) (Controls unexposed, sick), 2022 Madley-Dowd_UK (Topiramate) (Controls unexposed, sick) (Epilepsy), 2024
2
3.48
[
1.46
; 8.27]
143
289
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Bromley (Topiramate), 2016
1
1.00
[
0.43
; 2.32]
-
27
not evaluable
0.0
100.0
1.0
